Phase
Condition
Aids And Aids Related Infections
Hiv/aids
Hiv Infections
Treatment
E/C/F/TAF
E/C/F/TAF (Low Dose)
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Cohort 1
12 years to < 18 years of age at baseline
Weight greater than or equal to 35 kg (77 lbs)
Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
No prior use of any approved or experimental anti-HIV-1 drug for any length oftime
Cohort 2
6 years to < 12 years of age at baseline
Weight greater than or equal to 25 kg (55 lbs)
Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level accordingto the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviralregimen, without documented history of resistance to any component of E/C/F/TAFSTR.
Cohort 3
Age at baseline: ≥ 2 years old
Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs)
Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according tothe local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviralregimen, without prior history of resistance to any component of E/C/F/TAF STR
Exclusion
Key Exclusion Criteria:
Hepatitis B or hepatitis C virus infection
Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 monthsof the screening visit.
Individuals experiencing decompensated cirrhosis
Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Hospital Civil de Gualdalajara Fray Antonio Alcalde
Guadalajara, Jalisco 44280
MexicoSite Not Available
Be Part Yoluntu Centre
Cape Town, 7646
South AfricaSite Not Available
Desmond Tutu HIV Foundation
Cape Town, 7705
South AfricaSite Not Available
KIDCRU Ward J8
Cape Town, 7505
South AfricaSite Not Available
Mpati Medical Centre
Dundee, 3000
South AfricaSite Not Available
Gulam Latiff Private Practice
Durban, 4001
South AfricaSite Not Available
Clinical HIV Research Unit
Johannesburg, 2041
South AfricaSite Not Available
Empilweni Services and Research Unit (ESRU)
Johannesburg, 2092
South AfricaSite Not Available
Perinatal HIV Research Unit Baragwanath Hospital
Johannesburg, 1862
South AfricaSite Not Available
Perinatal HIV Research Unit
Soweto, 2013
South AfricaSite Not Available
The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
Pathumwan, Bangkok 10330
ThailandSite Not Available
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
Muang, Khon Kaen 40002
ThailandSite Not Available
The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
Bangkok, 10330
ThailandSite Not Available
Queen Savang Vadhana Memorial Hospital
Chon Buri, 20110
ThailandSite Not Available
Queen Savang Vadhana Memorial Hospital
Chonburi, 20110
ThailandSite Not Available
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002
ThailandSite Not Available
Joint Clinical Research Centre
Lubowa Hill, Kampala PO Box 10005
UgandaSite Not Available
Joint Clinical Research Centre
Kampala, PO Box 10005
UgandaSite Not Available
Miller's Children Hospital
Long Beach, California 90806
United StatesSite Not Available
Alta Bates Summit Medical Center
Oakland, California 94609
United StatesSite Not Available
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Children's Research Institute
Washington, District of Columbia 20010
United StatesSite Not Available
Children's National Medical Center
Washington, D.C., District of Columbia 20852
United StatesSite Not Available
University of South Florida - Department of Pediatrics
Tampa, Florida 33606
United StatesSite Not Available
Emory University School of Medicine
Atlanta, Georgia 30322
United StatesSite Not Available
New York University
New York, New York 10016
United StatesSite Not Available
SUNY Upstate Medical Center
Syracuse, New York 13210
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105-0371
United StatesSite Not Available
University of Zimbabwe - Clinical Research Centre
Belgravia, 263
ZimbabweSite Not Available

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